Bradley Estes, PhD, founder and chief executive officer of CytexOrtho, gave the winning presentation at the OrthoPitch Technology Competition at the AAOS Annual Meeting. CytexOrtho won for its novel implant designed to naturally restore joints rather than artificially replacing them.
Published 5/29/2024
|
Leah Lawrence
AAOS launched a brand-new and exciting technology competition at its 2024 AAOS Annual Meeting, designed to highlight innovative orthopaedic products. OrthoPitch provides an opportunity for companies to demonstrate new products and solutions to a group of industry experts, with finalists presenting live at the AAOS Annual Meeting. Contest terms and conditions are available online aaos.org/orthopitch.
In his introduction, Jason L. Dragoo, MD, FAAOS, chair of the AAOS Devices, Biologics, and Technology (DBT) Committee, said the brand-new event was a year in the making. More than 40 innovative companies applied. The applicants were narrowed down to four to be presented live: products from Biomedical Bonding AB, CytexOrtho, nView medical, and Solenic Medical.
One representative from each company gave a brief, live presentation to the audience and a panel of three judges: experienced medical technology entrepreneur Eric Major; former FDA Acting Branch Chief for the Orthopedic Joint Devices Branch and current Vice President of Regulatory Affairs at MCRA Dave McGurl; and Professor of Orthopedics and Regenerative Medicine at Mayo Clinic and DBT member Daniel Saris, MD, PhD. The final winner was selected based on panelist and audience votes.
Biomedical bonding
First up was Michael Malkoch, chairman and chief science officer of Biomedical Bonding, who presented Bonevolent, a medical adhesive and composite platform technology designed for hard-tissue treatments. A technique used in dentistry for decades, these resin-based implants can be tailored for each individual, providing personalized patient treatments.
“We are embarking on clinical trials with our first product, called Bonevolent Adhfix, which can be used on demand in the surgical room and made to fit the patient,” Mr. Malkoch explained. “It is a hybrid system that uses fixators or screws and then applies the viscus composite and hardens it.”
When questioned by Mr. Major about the timeline to get to product clearance, Mr. Malkoch said the company is currently looking for investors to pursue first-in-human clinical trials for low-loadbearing hand fractures and already has two clinical sites secured and ready to do the research.
CytexOrtho
Next up was Bradley Estes, PhD, founder and chief executive officer of CytexOrtho. CytexOrtho designed an implant to naturally restore joints instead of artificially replacing them. The product is currently being researched in the hip. Surgeons remove damaged tissue and replace it with the implant. The implant integrates into the joint space, replacing damaged tissue. Over time, cells move into the gaps in the layers of the implant and are slowly absorbed into the body.
“The implant is comprised of two very special components, one is a 3D-woven textile, and the other is a 3D-printed component,” Dr. Estes said. “The combination of these two components gives us an implant that recreates the form and structure of articular cartilage and bone.”
Dr. Saris commented that the devil is in the details and asked whether this implant requires the use of an open procedure. Dr. Estes explained that CytexOrtho is taking a multi-tiered approach: currently using an open dislocation but working on developing arthroscopy techniques.
“We have been funded by the [National Institutes of Health] for all the research and development that has gone into the implant,” Dr. Estes said. “The science behind our implant technology is solid.”
The technology has received FDA Breakthrough Device designation. CytexOrtho stated that it is currently looking to raise funding to help finish its phase 1 clinical trial and launch a phase 2 clinical trial.
nView Medical
Following Dr. Estes was Christian Atria, founder and chief executive director of nView Medical. He presented the nView s1 with true-map navigation.
This imaging system integrates the latest developments in low-dose radiograph imaging and artificial intelligence–enabled imaging algorithms to provide multiplanar, fluoroscopic, and augmented views derived from fast tomographic reconstructions of the patient during surgery. The platform also includes navigation that can be used for surgical guidance.
“Every surgeon can be a super surgeon if they have the right information, and that is what we are providing with nView,” Mr. Atria said during a video presentation. “We are trying to make surgery safer for all patients.”
During the judges’ questions, Mr. Major asked Mr. Atria about the company’s commercialization strategy. Right now, Mr. Atria said they are exploring the use of the product in pediatric scoliosis to prove that the technology works, but the company is looking for partners or funding to commercialize at scale and move into larger markets.
Solenic Medical
The final presentation was from James Y. Lancaster, chief executive officer of Solenic Medical. Solenic Medical has created an innovative, non-invasive treatment that harnesses the properties of alternating magnetic fields generated from external coils to eradicate biofilm on the surface of medical implants. This treatment could address infection, a major complication of various orthopaedic surgeries.
“Our sweet spot is not generating heat on the implant,” Mr. Lancaster said. “Our sweet spot is shaping the field and allowing surgeons to choose the level of thermal medicine that they desire.”
Mr. McGurl asked what treatment effect will be studied in first-in-human clinical trials of the product. Mr. Lancaster said that infection rates can vary widely in orthopaedics. The company is targeting the debridement, antibiotics, and implant-retention procedure for knee implants, which has a high relapse rate, as its first indication.
The winner
Ultimately, the winner was CytexOrtho. “What was most important to us, as the jury, was the likelihood of the product being a game-changer, the phase at which the company now has the product and the preparations, and the likelihood of them to be successful not just from a medical but also from a regulatory and financial perspective,” Dr. Saris said.
Among the prizes were a complimentary booth at the AAOS 2025 Annual Meeting, meetings with leading medical technology investors, complimentary regulatory or reimbursement assessment by an MRCA consultant, and one-seat access to Axiom Health’s Intelligence Platform.
“We are very excited to see the large amount of interest, the wonderful atmosphere, and the excellent job of the four finalists,” Dr. Saris said. “We look forward to next year and the progress of the current finalist in the future.”
Leah Lawrence is a freelance medical writer for AAOS Now.